TORONTO, Canada — Satellos Bioscience Inc. (NASDAQ: MSLE, TSX: MSCL) (“Satellos” or the “Company”), a clinical-stage biotechnology company developing novel therapies to treat degenerative muscle diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to SAT-3247 for the treatment of Duchenne.
“Fast Track designation represents an important validation of SAT-3247 and our commitment to transforming the treatment landscape for Duchenne,” said Frank Gleeson, co-founder and chief executive officer of Satellos. “Together with our Orphan Drug and Rare Pediatric Disease designations, this recognition further strengthens the momentum behind our clinical program. We believe SAT-3247’s unique regenerative mechanism has the potential to address a fundamental aspect of disease progression by re-establishing the biological signals needed for effective muscle repair and regeneration. As we advance our Phase 2 studies, we look forward to continuing our engagement with the FDA as we work to advance SAT-3247 for individuals and families affected by Duchenne.”
Fast Track is a process designed to facilitate the development and expedite the review of drugs that treat serious conditions and address unmet medical needs. Companies receiving Fast Track designation may be eligible for more frequent interactions with the FDA, rolling review of future marketing applications and, if relevant criteria are met, eligibility for Accelerated Approval and Priority Review.
The Company is currently advancing SAT-3247 through its ongoing Phase 2 BASECAMP and TRAILHEAD studies in children and adults living with Duchenne.
ABOUT SAT-3247
SAT-3247 is a proprietary, oral, small molecule drug candidate being developed by Satellos as a novel approach to regenerating skeletal muscle lost in Duchenne muscular dystrophy (DMD) and other degenerative muscle diseases or injury conditions. Satellos is advancing SAT-3247 as a potential treatment for DMD that is independent of dystrophin regardless of exon mutation status, with ongoing Phase 2 clinical studies, including TRAILHEAD, an open-label study in adult participants, and BASECAMP, a global, randomized, placebo-controlled study in pediatric participants.
ABOUT SATELLOS BIOSCIENCE INC.
Satellos is a clinical-stage drug development company advancing SAT-3247, a first-of-its-kind, orally administered small molecule therapy designed to enhance the body’s natural muscle repair and regeneration process in degenerative muscle diseases. SAT-3247 is being evaluated as a potential disease-modifying treatment, initially for DMD, in two Phase 2 clinical trials: BASECAMP in pediatrics and TRAILHEAD in adults. SAT-3247 targets AAK1, a protein that is a key regulator of the body’s natural muscle repair and regeneration biology, which Satellos discovered is disrupted in DMD and other degenerative conditions. By inhibiting AAK1, SAT-3247 is designed to re-establish a critical biochemical signal needed to guide this process, in a dystrophin-independent manner. This mechanistic feature offers SAT-3247 the potential for broad applicability as either a stand-alone treatment to potentially enhance muscle and function, or as adjunctive therapy alongside other approaches. Satellos has identified additional degenerative muscle diseases where enhancing muscle repair and regeneration may have therapeutic benefit and plans to pursue these opportunities in future clinical development. For more information, visit www.satellos.com.
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